FDA.reportPublic FDA data

Application 090478

Type
ANDA
Sponsor
INVAGEN PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDETABLET;ORAL5MGNoNo
002CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDETABLET;ORAL10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-8084Cyclobenzaprine HydrochlorideCyclobenzaprineNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
12634-528Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideApotheca Inc.ANDACurrent
31722-282Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideCamber PharmaceuticalsANDACurrent
31722-283Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideCamber PharmaceuticalsANDACurrent
45865-433Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideMedsource PharmaceuticalsANDACurrent
45865-433Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideMedsource PharmaceuticalsANDACurrent
50090-3253Cyclobenzaprine HydrochlorideCyclobenzaprineA-S Medication SolutionsANDACurrent
50090-3253Cyclobenzaprine HydrochlorideCyclobenzaprineA-S Medication SolutionsANDACurrent
50268-190Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideAvPAKANDACurrent
50268-190Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideAvPAKANDACurrent
50268-190Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideAvPAKANDACurrent
50268-191Cyclobenzaprine HydrochlorideCyclobenzaprineAvPAKANDACurrent
50436-0846Cyclobenzaprine HydrochlorideCyclobenzaprineUnit Dose ServicesANDACurrent
51655-973Cyclobenzaprine HydrochlorideCyclobenzaprineNorthwind PharmaceuticalsANDACurrent
53002-0521Cyclobenzaprine HydrochlorideCyclobenzaprineRPK Pharmaceuticals, Inc.ANDACurrent
53002-3080Cyclobenzaprine HydrochlorideCyclobenzaprineRPK Pharmaceuticals, Inc.ANDACurrent
53002-3080Cyclobenzaprine HydrochlorideCyclobenzaprineRPK Pharmaceuticals, Inc.ANDACurrent
55700-311Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-459Cyclobenzaprine HydrochlorideCyclobenzaprineLake Erie Medical DBA Quality Care Products LLCANDACurrent
58118-0846Cyclobenzaprine HydrochlorideCyclobenzaprineClinical Solutions Wholesale, LLCANDACurrent
58118-0846Cyclobenzaprine HydrochlorideCyclobenzaprineClinical Solutions Wholesale, LLCANDACurrent
58118-0846Cyclobenzaprine HydrochlorideCyclobenzaprineClinical Solutions Wholesale, LLCANDACurrent
60687-558Cyclobenzaprine HydrochlorideCyclobenzaprineAmerican Health PackagingANDACurrent
60687-558Cyclobenzaprine HydrochlorideCyclobenzaprineAmerican Health PackagingANDACurrent
61919-064CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEDIRECT RXANDACurrent
61919-064CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEDIRECT RXANDACurrent
61919-065CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEDirect RxANDACurrent
61919-305CYCLOBENZAPRINECYCLOBENZAPRINEDIRECT RXANDACurrent
61919-305CYCLOBENZAPRINECYCLOBENZAPRINEDIRECT RXANDACurrent
61919-544CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEDIRECT RXANDACurrent
63187-342Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideProficient Rx LPANDACurrent
63187-342Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideProficient Rx LPANDACurrent
63187-812Cyclobenzaprine HydrochlorideCyclobenzaprineProficient Rx LPANDACurrent
63187-812Cyclobenzaprine HydrochlorideCyclobenzaprineProficient Rx LPANDACurrent
63187-812Cyclobenzaprine HydrochlorideCyclobenzaprineProficient Rx LPANDACurrent
63187-812Cyclobenzaprine HydrochlorideCyclobenzaprineProficient Rx LPANDACurrent
63187-812Cyclobenzaprine HydrochlorideCyclobenzaprineProficient Rx LPANDACurrent
66267-064Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
66267-775Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
66267-775Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
67046-148Cyclobenzaprine HydrochlorideCyclobenzaprineCoupler EnterprisesANDACurrent
67296-1396Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideRedPharm Drug, Inc.ANDACurrent
67296-1396Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideRedPharm Drug, Inc.ANDACurrent
67296-1396Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideRedPharm Drug, Inc.ANDACurrent
67296-1396Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideRedPharm Drug, Inc.ANDACurrent
67296-1728Cyclobenzaprine HydrochlorideCyclobenzaprineRedPharm Drug, Inc.ANDACurrent
67296-1728Cyclobenzaprine HydrochlorideCyclobenzaprineRedPharm Drug, Inc.ANDACurrent
68071-3149Cyclobenzaprine HydrochlorideCyclobenzaprineNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3150Cyclobenzaprine HydrochlorideCyclobenzaprineNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3150Cyclobenzaprine HydrochlorideCyclobenzaprineNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3150Cyclobenzaprine HydrochlorideCyclobenzaprineNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3154Cyclobenzaprine HydrochlorideCyclobenzaprineNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3154Cyclobenzaprine HydrochlorideCyclobenzaprineNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3154Cyclobenzaprine HydrochlorideCyclobenzaprineNuCare Pharmaceuticals, Inc.ANDACurrent
68645-517Cyclobenzaprine HydrochlorideCyclobenzaprineLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-518Cyclobenzaprine HydrochlorideCyclobenzaprineLegacy Pharmaceutical Packaging, LLCANDACurrent
68788-7398Cyclobenzaprine HydrochlorideCyclobenzaprinePreferred Pharmaceuticals Inc.ANDACurrent
68788-7398Cyclobenzaprine HydrochlorideCyclobenzaprinePreferred Pharmaceuticals Inc.ANDACurrent
68788-7398Cyclobenzaprine HydrochlorideCyclobenzaprinePreferred Pharmaceuticals Inc.ANDACurrent
68788-9295Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
69097-845Cyclobenzaprine HydrochlorideCyclobenzaprineCipla USA Inc.ANDACurrent
69097-845Cyclobenzaprine HydrochlorideCyclobenzaprineCipla USA Inc.ANDACurrent
69097-845Cyclobenzaprine HydrochlorideCyclobenzaprineCipla USA Inc.ANDACurrent
69097-846Cyclobenzaprine HydrochlorideCyclobenzaprineCipla USA Inc.ANDACurrent
69097-846Cyclobenzaprine HydrochlorideCyclobenzaprineCipla USA Inc.ANDACurrent
69097-846Cyclobenzaprine HydrochlorideCyclobenzaprineCipla USA Inc.ANDACurrent
70518-0082Cyclobenzaprine HydrochlorideCyclobenzaprineREMEDYREPACK INC.ANDACurrent
70518-0082Cyclobenzaprine HydrochlorideCyclobenzaprineREMEDYREPACK INC.ANDACurrent
70518-0082Cyclobenzaprine HydrochlorideCyclobenzaprineREMEDYREPACK INC.ANDACurrent
70518-0082Cyclobenzaprine HydrochlorideCyclobenzaprineREMEDYREPACK INC.ANDACurrent
70518-0082Cyclobenzaprine HydrochlorideCyclobenzaprineREMEDYREPACK INC.ANDACurrent
70518-0082Cyclobenzaprine HydrochlorideCyclobenzaprineREMEDYREPACK INC.ANDACurrent
70518-0082Cyclobenzaprine HydrochlorideCyclobenzaprineREMEDYREPACK INC.ANDACurrent
70518-0211Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0390Cyclobenzaprine HydrochlorideCyclobenzaprineREMEDYREPACK INC.ANDACurrent
70518-0635Cyclobenzaprine HydrochlorideCyclobenzaprineREMEDYREPACK INC.ANDACurrent
70518-0635Cyclobenzaprine HydrochlorideCyclobenzaprineREMEDYREPACK INC.ANDACurrent
70518-0635Cyclobenzaprine HydrochlorideCyclobenzaprineREMEDYREPACK INC.ANDACurrent
70518-0635Cyclobenzaprine HydrochlorideCyclobenzaprineREMEDYREPACK INC.ANDACurrent
70518-0635Cyclobenzaprine HydrochlorideCyclobenzaprineREMEDYREPACK INC.ANDACurrent